(a) Groups of organisms which are or contain plant pests.
The organisms that are or contain plant pests are included in the taxa or group of organisms contained in the following list. Within any taxonomic series included on the list, the lowest unit of classification actually listed is the taxon or group which may contain organisms which are regulated. Organisms belonging to all lower taxa contained within the group listed are included as organisms that may be or may contain plant pests, and are regulated if they meet the definition of plant pest in § 340.1 4
Code of Federal Regulations
Footnote(s):
4 Any organism belonging to any taxa contained within any listed genera or taxa is only considered to be a plant pest if the organism “can directly or indirectly injure, or cause disease, or damage in any plants or parts thereof, or any processed, manufactured, or other products of plants.” Thus a particular unlisted species within a listed genus would be deemed a plant pest for purposes of § 340.2
, if the scientific literature refers to the organism as a cause of direct or indirect injury, disease, or damage to any plants, plant parts or products of plants. (If there is any question concerning the plant pest status of an organism belonging to any listed genera or taxa, the person proposing to introduce the organism in question should consult with APHIS to determine if the organism is subject to regulation.)
Code of Federal Regulations
Note:
Any genetically engineered organism composed of DNA or RNA sequences, organelles, plasmids, parts, copies, and/or analogs, of or from any of the groups of organisms listed below shall be deemed a regulated article if it also meets the definition of plant pest in § 340.1
.
(b) Exemptions.
(1)
A limited permit for interstate movement shall not be required for genetic material from any plant pest contained in Escherichia coli genotype K-12 (strain K-12 and its derivatives), sterile strains of Saccharomyces cerevisiae, or asporogenic strains of Bacillus subtilis, provided that all the following conditions are met:
(i)
The microorganisms are shipped in a container that meets the requirements of § 340.8(b)(3) ;
(ii)
The cloned genetic material is maintained on a nonconjugation proficient plasmid and the host does not contain other conjugation proficient plasmids or generalized transducing phages;
(iii)
The cloned material does not include the complete infectious genome of a known plant pest;
(iv)
The cloned genes are not carried on an expression vector if the cloned genes code for:
(A)
A toxin to plants or plant products, or a toxin to organisms beneficial to plants; or
(B)
Other factors directly involved in eliciting plant disease (i.e., cell wall degrading enzymes); or
(C)
Substances acting as, or inhibitory to, plant growth regulators.
(2)
A limited permit for interstate movement is not required for genetic material from any plant pest contained in the genome of the plant Arabiodopsis thaliana, provided that all of the following conditions are met:
(ii)
The cloned genetic material is stably integrated into the plant genome;
(iii)
The cloned material does not include the complete infectious genome of a known plant pest.
Code of Federal Regulations
[52 FR 22908, June 16, 1987, as amended at 53 FR 12913, Apr. 20, 1988; 55 FR 53276, Dec. 28, 1990; 58 FR 17056, Mar. 31, 1993]
As used in this part:
(a)
Administrator means the Administrator of the Cooperative State Research, Education, and Extension Service (CSREES) and any other officer or employee of the Department of Agriculture to whom the authority involved may be delegated.
(b)
Department means the Department of Agriculture.
(c)
Principal investigator means a single individual designated by the grantee in the grant application and approved by the Administrator who is responsible for the scientific and technical direction of the project.
(d)
Grantee means the entity designated in the grant award document as the responsible legal entity to whom a grant is awarded under this part.
(e)
Research project grant means the award by the Administrator of funds to a grantee to assist in meeting the costs of conducting, for the benefit of the public, an identified project which is intended and designed to establish, discover, elucidate, or confirm information or the underlying mechanisms relating to a research program area identified in the annual solicitation of applications.
(f)
Project means the particular activity within the scope of one or more of the research program areas identified in the annual solicitation of applications, which is supported by a grant award under this part.
(g)
Project period means the total length of time that is approved by the Administrator for conducting the research project as outlined in an approved grant application.
(h)
Budget period means the interval of time (usually 12 months) into which the project period is divided for budgetary and reporting purposes.
(i)
Awarding official means the Administrator and any other officer or employee of the Department to whom the authority to issue or modify research project grant instruments has been delegated.
(j)
Peer review group means an assembled group of experts or consultants qualified by training and experience in particular scientific or technical fields to give expert advice, in accordance with the provisions of this part, on the scientific and technical merit of grant applications in those fields.
(k)
Ad hoc reviewers means experts or consultants qualified by training and experience in particular scientific or technical fields to render special expert advice, whose written evaluations of grant applications are designed to complement the expertise of the peer review group, in accordance with the provisions of this part, on the scientific or technical merit of grant applications in those fields.
(l)
Research means any systematic study directed toward new or fuller knowledge and understanding of the subject studied.
(m)
Methodology means the project approach to be followed and the resources needed to carry out the project.